As the ICD population continues to grow at an exponential rate, the follow-up burden has also increased dramatically. In-hospital follow up visits are costly and time-consuming to the Physician, Cardiac Physiologist and patient. Currently, patients are usually seen at follow-up clinics every 3-6 months, depending on local protocols. The logistics of monitoring these devices have already placed a substantial and increasing burden on the follow up centre. In fact, it is estimated that in 2006 approximately 2,565,000 ICD follow-up1 visits were performed worldwide.
The number of patients with ICD’s will continue to increase due to an aging population, cardiovascular disease prevalence, broadening CRM indications and market penetration. Traditionally, patients are seen at device clinics every 3-6 months. The bulk of these routine visits involve data collection only, and in fact, 55% of these visits do not result in any changes to the medical therapy for the patients.1
The availability of remote monitoring of implantable cardiac devices requires a change in the follow-up model and care pathway protocols. Remote monitoring technology reduces the need for face-to-face clinic visits and may facilitate, if needed, visits triggered by a clinical event.
The TRUST trial (Lumax-T/Lumos-T safely RedUceS rouTine office device follow-up) is a controlled multi-center, prospective, randomized trial which is the first and largest study in the CRM industry to provide clinical evidence of the safety and efficacy of remote monitoring. It’s a randomized trial with 1443 ICD patients enrolled to-date in 105 centers in the US and Canada. The goal of this trial is to demonstrate that the BIOTRONIK Home Monitoring® system can safely reduce in-office follow-ups, and detect silent clinical events early.
Study design:
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Multi-center, prospective, controlled, randomized trial
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1,443 patients enrolled to-date, 1,312 patients with at least one follow-up
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105 sites in US & Canada
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Patients will be implanted with Lumax or Lumos VR-T/DR-T
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Any legally marketed leads may be used
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Any legally marketed leads may be used
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Two group randomization (2:1 ratio):
- BIOTRONIK Home Monitoring = ON
- BIOTRONIK Home Monitoring = OFF -
Patient participation and follow up period: Up to 15 months
Key Inclusion Criteria:
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Implanted within the last 45 days or being considered for implantation of a BIOTRONIK Lumax/Lumos ICD with Home Monitoring technology
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Ability to use Hone Monitoring system
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Ability to give informed consent
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Ability to return to clinic for protocol required follow-ups for 15 months
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At least 18 years old
Key Exclusion Criteria:
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Patients who are pacemaker dependent
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Patients who are currently enrolled in any other cardiac clinical investigation
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Patients who do not fulfill all inclusion criteria
Primary Objective:
Demonstrate that BIOTRONIK Home Monitoring system can safely reduce in-office follow-ups
Primary Endpoint – Effectiveness
To compare the number of in-office follow-ups for patients in BIOTRONIK Home Monitoring group vs. Control group
Primary Endpoint – Safety
To compare the composite safety event rate (SER) between the two groups:
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Death
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Incidence of stroke
Events requiring surgical interventions (e.g., device explants, lead revisions and ablations).
BIOTRONIK Home Monitoring group
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Requires Home Monitoring follow-ups at 3, 6, 9, 12 and 15 months post-implant.
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Requires an office device follow-up after 3 and 15 months.
Control group
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Requires office device follow-ups at 3, 6, 9, 12 and 15 months post-implant
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Home Monitoring turned off
Results and Conclusions:
In comparison with the control group of patients enrolled in conventional in-hospital follow up, clinical trial data from TRUST show that remote monitoring:
Reduces the number of in-office follow-up visits, while maintaining patient safety.
The remote monitoring group had approximately half the total number of office visits as compared to the conventional follow-up group while achieving the same patient outcomes.
Leads to earlier detection of arrhythmic events.
In the remote monitoring group, the time from onset of the arrhythmic event to evaluation was reduced by 21-35 days compared to the control group, depending on the type of arrhythmia detected.
Drives efficient use of clinic time.
Eighty-nine percent of remote monitoring alerts were managed remotely and required no follow-up office visit. About 30 percent of unscheduled office visits among patients in both the control and study groups required physician interaction and were considered actionable. * However, unscheduled office visits that were triggered by the remote monitoring system nearly doubled the rate of treatment; more than 51 percent led to some action by the clinician, making better use of clinic time.
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Quotes about TRUST:
”The data demonstrates that the BIOTRONIK Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events,” said Dr. Niraj Varma, TRUST principal investigator, Cleveland Clinic. “Based on the results from this large-scale clinical trial, I believe remote monitoring may improve the way physicians care for patients with implanted cardiac devices.”
“The study results show that remote monitoring facilitates follow-up care and, very importantly, enhances patient safety, which can provide patients with additional security,” said Dr. Andrew Epstein, TRUST principal investigator and professor of medicine in the division of cardiovascular disease at the University of Alabama at Birmingham.
“Decreasing the number of non-actionable, scheduled and unscheduled office visits through remote monitoring will ease the pressure of overloaded follow-up cardiac clinics. This will permit physicians to focus on patients who actually require intervention,” said Dr. Charles Love, TRUST principal investigator and director of arrhythmia device services and associate investigator, Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Medical Center.
Trail Executive committee:
Niraj Varma, M.D. Principal Investigator, Cleveland Clinic, Cleveland, OH
Venkateshwar Gottipaty M.D. South Carolina Heart, Columbia, SC
Shumel Inbar, M.D. Odessa, TX
John Ip, M.D. Ingham Hospital, Lansing, MI
Charles Love, M.D. Ohio State University, Columbus, OH
Suresh Neelagaru, M.D. Lone Star Arrhythmia & HF, Amarillo, TX
Farrell Pierson, M.D. Knoxville, TN
Robert Schweikert, M.D. Cleveland Clinic, Cleveland, OH
References:
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Wilkoff Europace 2008, 10, 707
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Joseph et al. Remote Interrogation and Monitoring of Implantable Cardioverter Defibrillator., JICE 2004; 11: 161-166
* An actionable follow-up visit is defined when there is:
- An ICD lead system revision
- An initiation or up-titration of anti-arrhythmic medications
- A clinically significant ICD re-programming, for example:
• Increases in pacing output of > 1.0 V
• Changes in VT/SVT algorithm/settings for the purpose of preventing inappropriate shocks and delivering appropriate shocks
• Changes in the programming of the lowest tachy rate boundary for the purpose of preventing inappropriate shocks
